Brittney Crawford
Lutz,FL
Summary
Motivated and detail-oriented Clinical Research professional with experience in coordinating and managing clinical trials across multiple therapeutic areas. Strong understanding of ICH-GCP guidelines, FDA regulations, and clinical operations. Adept at maintaining regulatory compliance, supporting monitoring visits, and fostering effective communication with investigators, sponsors, and site staff.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator II
Theia Clinical Research, LLC
06.2023 - Current
- Coordinate all aspects of clinical trial execution for Phase II-III studies in gastroenterology, cardiovascular, observational, and vaccine research.
- Lead subject recruitment strategies using EMR platforms, call lists, and chart reviews, contributing to the enrollment of over 140 participants in 2023.
- Conduct informed consent discussions in compliance with ICH-GCP, FDA, and IRB guidelines, ensuring patient understanding and proper documentation.
- Perform study visit procedures including vitals, ECGs, sample collection, questionnaires, and protocol-specific assessments within designated visit windows.
- Manage electronic and paper-based source documentation and complete accurate data entry in EDC systems, resolving queries in collaboration with CRAs and Data Management.
- Maintain and organize regulatory binders (ISF), patient files, and essential documents throughout the study lifecycle in compliance with sponsor and GCP expectations.
- Coordinate with monitors during SIVs, routine monitoring, and closeout visits, addressing findings and implementing corrective actions when needed.
- Submit IRB documents, protocol amendments, and safety reports, and track approvals to ensure continuous regulatory compliance.
- Process and ship lab specimens according to protocol-specific requirements and IATA standards, maintaining chain-of-custody documentation.
- Collaborate with CROs, sponsors, and internal team members to meet study timelines and ensure high-quality trial execution
Clinical Research Assistant
Theia Clinical Research, LLC
01.2023 - Current
- Supported clinical trial coordination including screening, EMR review, and recruitment tracking.
- Collected and processed biological samples per protocol specifications.
- Maintained essential documents and assisted in regulatory binder updates.
- Ensured accurate data entry into EDC systems and supported query resolution.
- Helped prepare site for SIVs, IMVs, and closeout visits.
- Worked collaboratively with study teams to uphold protocol integrity and subject safety.
Healthcare Receptionist
The Wrist and Hand Center
05.2021 - 12.2022
- Coordinated patient appointments, insurance verification, authorizations, and surgical bookings.
- Supported front desk operations and created organized medical charts for legal and clinical use.
Education
Bachelor of Science - Biological Health Science, Nutrition
University of South Florida
05-2021
Skills
- Electronic Data Capture Systems
- IWRS
- CTMS
- Microsoft Office Suite
- EMR Systems
- Lab Processing
- Data collection
- Patient recruitment
- Phlebotomy
- Participant screening
- Informed consent
- Trial management
- Specimen collections
Relevant Coursework
- Anatomy and Physiology I & II
- Biology I & II
- Biomedical Ethics
- Foundations of Public Health
- Immunology
- General Chemistry I & II
- Organic Chemistry I
- Microbiology
- Scientific and Medical Terminology
Certification
- ACRP CCRC (April 2025)
- IATA Shipping Certification
- Good Clinical Practice (GCP)
- BLS/CPR Certification
Accomplishments
Successfully recruited 150 patients across a diverse portfolio of clinical trials, encompassing an observational oncology study, a vaccine efficacy trial, and an in-hospital cerebrovascular accident (CVA) trial.
Timeline
Lead Clinical Research Coordinator II
Theia Clinical Research, LLC
06.2023 - Current
Clinical Research Assistant
Theia Clinical Research, LLC
01.2023 - Current
Healthcare Receptionist
The Wrist and Hand Center
05.2021 - 12.2022
Bachelor of Science - Biological Health Science, Nutrition
University of South Florida
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